CompletedNot Applicable

Accuracy of Ultrasound in Identification of Cricothyroid Membrane: A Randomized Clinical Trial

Canada223 participantsStarted 2012-10

Plain-language summary

Routine surgery requires artificial breathing through the placement of a plastic tube into the patient's windpipe via mouth or nose. This tube serves as the source of providing oxygen to the patients during surgery. Difficulties during insertion of this tube may lead to serious complications and during this life-threatening crisis the only way to provide oxygen to the patient is by the help of a procedure called cricothyrotomy (CTY). CTY is a life saving procedure that involves an incision on the patient neck at a very precise location called Cricothyroid Membrane (CTM). The current method of identifying this location is by palpation of neck cartilages by the operator. The incorrect identification of the CTM could lead to many complications. In certain patients such as obese or distorted neck features the identification of CTM would be difficult. Ultrasound (US) has improved the success rate of many anesthesia procedures .Its use has been described for identification of neck structures; however, this technique of localization has not been validated against the gold standard which is the use of CT scan. The purpose of our study is to determine the precision of identifying the CTM using the US versus the conventional finger palpation when compared to the gold standard.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: ASA physical status I-III patients aged ≥ 18 with neck pathology who were scheduled for a neck CT scan at University Health Network. All patients recruited in the study had neck pathologies including previous neck surgery, irradiation and/or neck mass. Exclusion Criteria: patients who were unable to lie flat, unable to maintain a neutral neck position and those who refused to participate in the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

accuracy in identification of the Cricothyroid Membrane

Timeframe: Less than 1 min

Trial details

NCT IDNCT01725828

SponsorSamuel Lunenfeld Research Institute, Mount Sinai Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-06

View on ClinicalTrials.gov More Difficult Breathing trials